Certificates of Analysis are available electronically at www.atcc.org, or by hardcopy upon request.

Certified Reference Material produced under an ISO Guide 34:2009 accredited process. For use in testing and calibration in ISO 17025 accredited laboratories, to challenge assay performance, validate or compare test methods, and to establish sensitivity, linearity and specificity during assay validation or implementation.

For sterility testing, not more than five passages from the ATCC culture should be used.

Applications:
Used to assign ratios of the human epidermal growth factor 2 gene (HER2; the official gene symbol ERBB2) to unamplified reference genes. Measurements of the amplification (increased copies) of the HER2 gene in breast cancer samples are used as a biomarker for determining the classification for breast cancers

SRM NIST-2373 consists of genomic DNA extracted from five breast cancer cell lines with different amounts of amplification of the HER2 gene. The five purified genomic DNAs were solubilized in a buffer consisting of 10 mmol/L tris(hydroxymethyl)aminomethane and 0.1 mmol/L ethylenediaminetetraacetic acid disodium salt (EDTA) pH 8.0 (TE–4). The five components are genomic DNA materials derived from human cell lines SK-BR-3, MDA-MB-231, MDA-MB-361, MDA-MB-453, and BT-474, labeled A, B, C, D, and E, respectively. A unit of SRM 2373 consists of five vials, one of each component, containing approximately 100 μL of DNA solution. Each of these vials is labeled and is sealed with a color-coded screw cap.

See the NIST Certificate of Analysis for directions for use and quality control specifications.